Enhanced Moisturizing Lotion Compositions

ABSTRACT

A moisturizing lotion composition includes water and propylene glycol having a concentration of 21.0 to 37.5 wt % of the moisturizing lotion composition. In addition, the moisturizing lotion composition includes aloe vera having a concentration of 0.50 to 4.0 wt % of the moisturizing lotion composition, and vervain extract having a concentration of 0.50 to 4.0 wt % of the moisturizing lotion composition. In addition, the moisturizing lotion composition includes willow bark extract having a concentration of 0.50 to 0.20 wt % of the moisturizing lotion composition. Further, the moisturizing lotion composition includes chamomilla recutita extract having a concentration of 0.05 to 0.40 wt % of the moisturizing lotion composition, wherein a ratio of the concentration of the propylene glycol to the concentration of the chamomilla recutita extract is between 4.5 and 5.5.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. nonprovisional patentapplication Ser. No. 17/010,123 filed Sep. 2, 2020, entitled “EnhancedMoisturizing Lotion Compositions” which claims benefit of U.S.provisional patent application No. 62/895,037 filed Sep. 3, 2019,entitled “Enhanced Moisturizing Lotion Compositions” and U.S.provisional patent application No. 62/994,155 filed Mar. 24, 2020,entitled “Enhanced Moisturizing Lotion Compositions,” all of which arehereby incorporated herein by reference in their entirety for allpurposes.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

BACKGROUND

Embodiments disclosed herein relate generally to topical moisturizinglotions. More specifically, embodiments disclosed herein relate totopical moisturizing lotions for treating skin irritation, inflammation,and discomfort.

Many individual suffer from chronic or acute skin irritation,inflammation, or discomfort. Such symptoms may be due to a variety ofcauses including preexisting skin disorders or diseases (e.g., eczema),exposure to a particular substance (e.g., a poisonous compound, certainchemicals in beauty products, poison ivy, etc.), insect bites, etc. Thespectrum of resulting symptoms can as minor as some localized redness toextreme pain and discomfort.

BRIEF SUMMARY

An embodiment of a moisturizing lotion composition comprises water,propylene glycol having a concentration of 21.0 to 37.5 wt % of themoisturizing lotion composition,

aloe vera having a concentration of 0.50 to 4.0 wt % of the moisturizinglotion composition, vervain extract having a concentration of 0.50 to4.0 wt % of the moisturizing lotion composition, willow bark extracthaving a concentration of 0.50 to 0.20 wt % of the moisturizing lotioncomposition, and chamomilla recutita extract having a concentration of0.05 to 0.40 wt % of the moisturizing lotion composition, wherein aratio of the concentration of the propylene glycol to the concentrationof the chamomilla recutita extract is between 4.5 and 5.5. In someembodiments, the moisturizing lotion comprises argan oil having aconcentration of 0.02 to 0.30 wt % of the moisturizing lotioncomposition. In some embodiments, the moisturizing lotion comprises analgae extract having a concentration of 1.5 to 3.0 wt % of themoisturizing lotion composition. In certain embodiments, themoisturizing lotion comprises panthenol having a concentration of 0.25to 2.0 wt % of the moisturizing lotion composition. In certainembodiments, the water is de-ionized water having a concentration of 40to 85 wt % of the moisturizing lotion composition. In some embodiments,the concentration of the propylene glycol is 22.5 wt % to 31.3 wt %. Insome embodiments, the concentration of the aloe vera is 0.9 to 1.25 wt%. In certain embodiments, the concentration of the chamomilla recutitaextract is 0.09 to 0.13 wt % of the moisturizing lotion composition. Incertain embodiments, a ratio of the concentration of the aloe vera tothe concentration of the vervain extract is between 0.90 and 1.10. Incertain embodiments, the moisturizing lotion comprises a secondarycompound including alcohol having a concentration of 40 to 100 wt % ofthe secondary compound.

An embodiment of a moisturizing lotion composition comprises de-ionizedwater, propylene glycol having a concentration of 12.5 to 50.0 wt % ofthe moisturizing lotion composition, aloe vera having a concentration of0.5 to 2.0 wt % of the moisturizing lotion composition, vervain extracthaving a concentration of 0.50 to 4.0 wt % of the moisturizing lotioncomposition, chamomilla recutita extract having a concentration of 0.07to 1.5 wt % of the moisturizing lotion composition, and panthenol havinga concentration of 0.25 to 2.0 wt % of the moisturizing lotioncomposition, and willow bark extract having a concentration of 0.09 to0.13 wt % of the moisturizing lotion composition, wherein a ratio of theconcentration of the propylene glycol to the concentration of thechamomilla recutita extract is between 4.5 and 5.5, wherein a ratio ofthe concentration of the propylene glycol to the concentration of thepanthenol is between 45.0 and 55.0. In some embodiments, themoisturizing lotion comprises an antimicrobial compound. In someembodiments, the antimicrobial compound comprises diazolidinyl ureahaving a concentration of 0.14 to 0.55 wt % of the moisturizing lotioncomposition, or iodopropynyl butylcarbamate having a concentration 0.01to 0.05 wt % of the moisturizing lotion composition. In certainembodiments, the moisturizing lotion comprises a secondary compoundincluding alcohol having a concentration of 40 to 100 wt % of thesecondary compound. In certain embodiments, a ratio of the concentrationof the chamomilla recutita extract to the concentration of the willowbark extract is between 0.80 and 1.20. In some embodiments, themoisturizing lotion comprises argan oil having a concentration of 0.04to 0.07 wt % of the moisturizing lotion composition, wherein a ratio ofthe concentration of the Chamomilla recutita extract to theconcentration of the argan oil is between 1.5 and 2.5. In someembodiments, a ratio of the concentration of the panthenol to theconcentration of the chamomilla recutita extract is between 4.0 and 6.0.

Embodiments described herein comprise a combination of features andcharacteristics intended to address various shortcomings associated withcertain prior compositions and methods. The foregoing has outlinedrather broadly the features and technical characteristics of thedisclosed embodiments in order that the detailed description thatfollows may be better understood. The various characteristics andfeatures described above, as well as others, will be readily apparent tothose skilled in the art upon reading the following detailed descriptionand examples. It should be appreciated that the conception and thespecific embodiments disclosed may be readily utilized as a basis formodifying or designing other compositions and methods for carrying outthe same purposes as the disclosed embodiments. It should also berealized that such equivalent constructions do not depart from thespirit and scope of the principles disclosed herein.

DETAILED DESCRIPTION

The following discussion is directed to various exemplary embodiments.However, one of ordinary skill in the art will understand that theexamples disclosed herein have broad application, and that thediscussion of any embodiment is meant only to be exemplary of thatembodiment, and not intended to suggest that the scope of thedisclosure, including the claims, is limited to that embodiment.

Certain terms are used throughout the following description and claimsto refer to particular features or components. As one skilled in the artwill appreciate, different persons may refer to the same feature orcomponent by different names. This document does not intend todistinguish between components or features that differ in name but notfunction.

In the following discussion and in the claims, the terms “including” and“comprising” are used in an open-ended fashion, and thus should beinterpreted to mean “including, but not limited to . . . ” In addition,as used herein “applying” may include any method of introducing acomposition or substance into contact with the skin, such as by beingrubbed, poured, sprinkled, sprayed, or combinations thereof. Further, asused herein, a “cosmetic use” includes any use intended to improve theaesthetic appearance of the skin, such as by cleansing, beautifying,promoting attractiveness, or combinations thereof. A cosmetic benefit istypically visual or aesthetic, and can be evaluated using subjectiveand/or objective assays known in the art. As used herein, a“dermopharmaceutical use” includes uses intended for the treatment,mitigation or prevention of a disease or disorder of the skin, and/orintended to affect the structure or a function of the skin. Adermopharmaceutical use typically has a physiological, pharmacological,and/or therapeutic effect on the skin. A dermopharmaceutical use mayresult in an improved aesthetic appearance of the skin by virtue of itsphysiological, pharmacological, or therapeutic effects. Adermopharmaceutical benefit can be evaluated using subjective and/orobjective assays known in the art. As used herein, an “antimicrobialuse” is a use that targets, kills, inactivates, or slows the growth ofmicroorganisms, and thus is defined broadly herein to include antibioticuses, antibacterial uses, antiviral uses, and antiseptics uses. Ingeneral, antibiotic uses are those that target and/or kill bacteria,fungi, parasites, or combinations thereof. Antibacterial uses are thosethat target and/or kill bacterial cells, and may rely on a bacteriocidalthat deteriorates the integrity of cell walls and/or a bacteriostaticthat inhibits the growth and/or reproduction of bacterial cells.Antiviral uses are those that kill viruses, inhibit the growth ofviruses, or otherwise target viruses. Antiseptics are substancestypically used on bodily tissues (e.g., skin) to reduce the possibilityof infections, sepsis, or putrefaction, and are generally distinguishedfrom antibiotics, which are internally transportable via the lymphaticsystem within the body. Thus, antimicrobial uses may include the use ofcompounds usable outside of the body only (e.g., on the face or hands),uses within the body (e.g., within the nasal passages, mucousmembranes), and uses that may or may not involve compounds transportablevia the lymphatic system. As described in more detail below,coronaviruses are a group of related viruses defined broadly to include,for example: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2), cause of Coronavirus Disease 2019 (COVID-19); Severe AcuteRespiratory Syndrome virus (SARS-CoV), cause of Severe Acute RespiratorySyndrome (SARS); and Middle East Respiratory Syndrome Coronavirus(MERS-CoV), cause of the Middle East Respiratory Syndrome (MERS), andHuman Coronaviruses (HCoVs)]. It should be appreciated that recentresearch suggests that coronaviruses, including SARS-CoV-2, SARS-CoV,MERS-CoV, and HCoVs can persist on inanimate surfaces like metal, glass,or plastic for up to 9 days, but can be efficiently inactivated withinone minute in response to contact with surface disinfectant comprising,for example, 62% to 71% ethanol, 0.5% hydrogen peroxide or 0.1% sodiumhypochlorite, as described for example in Persistence of Coronaviruseson Inanimate Surfaces and Their Inactivation With Biocidal Agents by G.Kampf et al. Journal of Hospital Infection, Volume 104, Issue 3, March2020, Pages 246-251, which is hereby incorporated herein by reference inits entirety. As used herein, a “dermal delivery” refers to a process ofmass transport of active ingredients applied on the skin to various skinstrata. In comparison, as used herein a “transdermal delivery” refers tothe entire process of mass transport of substances applied on the skinsurface and includes their absorption by each skin strata, the strata'suptake by microcirculation, and the further distribution in the outersystemic circulation to at least a minor degree. As used herein, theterm “antimicrobial” refers to an agent that kills or prohibits thegrowth of microorganisms such as bacteria, fungals, viruses, andparasites. Thus, antimicrobials include antibacterials (e.g.,bactericides), antivirals, antiparasitics, and antifungals.

As used herein, the terms “approximately,” “about,” “substantially,” andthe like mean within 10% (i.e., plus or minus 10%) of the recited value.Unless the context dictates the contrary, all ranges set forth hereinshould be interpreted as being inclusive of their endpoints, andopen-ended ranges should be interpreted to include only commerciallypractical values. Similarly, all lists of values should be considered asinclusive of intermediate values unless the context indicates thecontrary.

Embodiments of compositions and methods for using same as disclosedherein may be used for cosmetic uses, dermopharmaceutical uses,antimicrobial uses, or combinations thereof. Such compositions maygenerally be referred to herein as “moisturizing lotion compositions,”which can be used to treat the skin, protect the skin, improve thecondition of the skin, improve the aesthetic appearance of skin, orcombinations thereof.

In general, embodiments of compositions disclosed herein (e.g.,moisturizing lotion compositions) may be suitable for use on skin tomoisturize, hydrate, reduce inflammation, reduce irritation, reducepain, or combinations thereof. For example, the properties ofembodiments of moisturizing lotion compositions disclosed herein may beparticularly beneficial for treating eczema, psoriasis, rosacea, ordermatitis including: contact dermatitis, photo dermatitis, seborrheicdermatitis, nummular dermatitis, stasis dermatitis, dermatitisherpetiformis, atopic dermatitis, and allergic dermatitis. According tosome embodiments, the moisturizing lotion compositions disclosed hereinis suitable for treating diabetic neuropathy and reducing nerve pain ofthe skin. For example, some embodiments of compositions disclosed hereincontain combinations of compounds that exhibit analgesic (e.g., painrelieving) benefits that are enhanced by a dermal or transdermaldelivery behavior of the compositions, which offers the potential toincrease the degree of pain relief and/or reduce the time to achievesuch pain relief. In some testing described in more detail below, theonset of pain relief following application of embodiments ofmoisturizing lotions described herein resulted in less than 5 minutes ofapplication. In addition, the moisturizing and/or hydration propertiesof some embodiments of compositions disclosed herein offer the potentialto reduce sagging, reduce scarring, reduce age spots, reduce wrinkles,or combinations thereof. Similarly, some embodiments of compositionsdisclosed herein may be beneficial for treating skin damage and/orirritation associated with chafing, sunburn, sensitive skin, dry skin,rough skin, flaky skin, red skin, irritated skin, and itchy skin. Inother instances, the anti-inflammatory properties of embodimentsdisclosed herein may improve acne, blisters, rash, or hives.

Embodiments of moisturizing lotion compositions will now be described.Such moisturizing lotion compositions include a plurality of compoundsor ingredients that are uniformly and homogeneously blended together tooffer potential for synergistic benefits in treating the skin. Morespecifically, embodiments of moisturizing lotion compositions disclosedherein include one or more of the following: skin conditioning agent(s),aloe vera, algae extract, vervain extract, an anti-inflammatory agent,cationic polymer(s), film forming barrier(s), emollient(s), cationic lowhumidity humectant(s), willow bark extract, antifungal and/orantibacterial compound(s), cetyl alcohol, surfactant(s) and/or emulsionagent(s), anti-wrinkle agent(s), alpha hydroxyl acid(s), lipid(s) and/ormonoglyceride(s), and anti-oxidant agent(s). One or more of theforegoing ingredients are mixed in a solvent, and in particular water,to form an aqueous solution. In some embodiments, a fragrance may alsobe added.

Embodiments of the moisturizing lotion composition can include a varietyof types of skin conditioning agents including, without limitation,propylene glycol. In such embodiments, the propylene glycol has aconcentration (expressed as a wt % of the moisturizing lotioncomposition) ranging from about 12.5 wt % to about 40.0 wt %,alternatively ranging from about 18.7 wt % to about 37.5 wt % of themoisturizing lotion composition, alternatively ranging from about 21.0wt % to 37.5 wt % of the moisturizing lotion composition, andalternatively from about 22.5% to about 31.3% wt % of the moisturizinglotion composition. The skin conditioning agent (e.g., propylene glycol)acts as a dermal and/or transdermal delivery agent, thereby assistingwith and facilitating penetration of the skin.

Other skin conditioning agent(s) such as chamomilla recutita extract maybe used alone or in combination with propylene glycol. In suchembodiments, the Chamomilla recutita extract has a concentration(expressed as a wt % of the moisturizing lotion composition) rangingfrom about 0.05 wt % to about 0.40 wt %, alternatively ranging fromabout 0.07 wt % to about 0.15 wt %, and alternatively ranging from about0.09 wt % to about 0.13 wt %.

Chamomilla recutita extract functions as a skin conditioning agent bymoisturizing the skin and restoring suppleness. In addition, chamomillarecutita extract is an antioxidant that protects skin from free-radicaldamage.

Chamomilla recutita extract also provides antiseptic andanti-inflammatory properties. Such properties can aid in fading spots onthe skin, eliminating scars, and treating acne. In addition, chamomillarecutita extract can provide analgesic (e.g., pain relieving) benefitsas described in Clinical Evaluation of Fluid Extract of Chamomillarecutita for Oral Aphthae, M. Ramos et al., Journal of Drugs Dermatol.2006; 5(7):612-617, which is hereby incorporated herein by reference inits entirety. Further, flavinoids in chamomilla recutita extract cansooth and calm the skin, and offer the potential to improve the speed atwhich damaged skin heals. Accordingly, chamomilla recutita extract maybe particularly beneficial in treating dry skin, eczema, psoriasis, andskin irritation. Chamomilla recutita extract may also be particularlybeneficial for with particularly sensitive skin as it isanti-irritating, non-comedogenic, and hypoallergenic.

In embodiments described in more detail below where the moisturizinglotion composition is used to enhance the antimicrobial efficacy ofsecondary compounds applied to the skin, the chamomilla recutita extractmay work in combination with the panthenol, aloe vera, and salicylicacid to further sooth skin irritation and further increase theantimicrobial efficacy of such secondary compounds.

Embodiments of the moisturizing lotion composition can include aloe verasuch as aloe barbadensis, aloe barbadensis leaf juice, aloe vera gel,aloe vera extract, or combinations thereof. In such embodiments, thealoe vera has a concentration (expressed as a wt % of the moisturizinglotion composition) ranging from about 0.50 wt % to about 4.00 wt %,alternatively ranging from about 0.75 wt % to about 1.50 wt %, andalternatively ranging from about 0.90 wt % to about 1.25 wt %.

The aloe vera is an anti-inflammatory and provides analgesic (i.e., painrelieving) effects. The aloe vera also provides skin calming (soothingand cooling), moisturizing, and anti-wrinkle properties. Consequently,aloe vera may be particularly beneficial for treating burns, eczema, andrelated irritation and pain. Such benefits may be enhanced by improveddermal and/or transdermal delivery properties of the moisturizing lotioncomposition.

In embodiments described in more detail below in which the moisturizinglotion composition is used to enhance the antimicrobial efficacy of oneor more secondary compounds applied to the skin, the aloe vera may soothor otherwise mitigate skin irritation, thereby allowing higherconcentrations of antimicrobial agents to be applied to sensitive skinareas as compared to skin that has not been treated with themoisturizing lotion composition. Thus, for instance, application of themoisturizing lotion composition may enable hand sanitizers with higherconcentrations of alcohol to be applied to skin, face, or nasal passageswhen the moisturizing lotion composition is applied to such areas incombination with the sanitizer (e.g., before, simultaneous with, orafter application of the sanitizer). Similarly, the aloe vera prolongthe period of time the skin can be exposed to such secondary compounds.As a result, the enhancements to the antimicrobial efficacy of suchsecondary compounds provided by aloe vera may be two-fold, as the shortterm effectiveness may be increased by the higher concentrations ofantimicrobial agents (e.g. alcohol, etc.), and the long termeffectiveness may be increased as the antimicrobial agents may remain onthe skin for a longer period of time.

Embodiments of the moisturizing lotion composition can include algaeextract derived or extracted from a variety of sources including,without limitation, freshwater algae species such as green algae, redalgae, brown algae, or combinations thereof; seaweed; marine algae(e.g., kelp extracts such as alginate); cyanobacteria or “blue-greenalgae;” and combinations thereof. In embodiments described herein, redor brown algae extract are particularly preferred. The algae extract hasa concentration (expressed as a wt % of the moisturizing lotioncomposition) ranging from about 1.0 wt % to 8.0 wt %, alternativelyranging from about 1.5 wt % to about 3.0 wt %, and alternatively rangingfrom about 1.8 wt % to about 2.5 wt %.

The algae extract functions as an antioxidant, moisturizes the skin,normalizes the moisture content of the skin, and provides suppleness,which can result in anti-aging characteristics. In addition, the algaeextract provides lubrication and hydration to the skin. Algae extract isa non-irritating and noncomedogenic. Accordingly, embodiments of themoisturizing lotion compositions including algae extract offer thepotential to provide improved modes and rates for hydration andlubrication, as well as delivery of other ingredients of themoisturizing lotion composition into the epidermis. The algae extractmay also provide analgesic (e.g., pain relieving) benefits and/orfacilitate analgesic benefits provided by other constituents of themoisturizing lotion composition.

Embodiments of the moisturizing lotion composition can include vervainextract. In such embodiments, the vervain extract included in themoisturizing lotion composition has a concentration (expressed as a wt %of the moisturizing lotion composition) ranging from about 0.50 wt % toabout 4.00 wt %, alternatively ranging from about 0.75 wt % to about1.50 wt %, and alternatively ranging from about 0.90 wt % to about 1.25wt %.

Vervain extract is an anti-oxidant, which may work in synergy withessential derivatives to beneficially scavenge free radicals. Thevervain extract may also enhance prostaglandins, which stimulatesextracellular transmission of the active ingredients of the moisturizinglotion composition. In addition, vervain extract may provide analgesic(e.g., pain relieving) benefits, as well as function as a skinconditioning agent with emollient properties. Without being limited byany theory, vervain extract is also believed to stimulate circulation asan arterial vasodilator and as a decongestive on vein flow, which mayenhance the rate of dispersion of one or more of the ingredients of themoisturizing lotion composition and/or enhance the rate of pain relief.

Embodiments of the moisturizing lotion composition can include one ormore anti-inflammatory agents including, without limitation, panthenol.In embodiments including panthenol as an anti-inflammatory agent, thepanthenol has a concentration (expressed as a wt % of the moisturizinglotion composition) ranging from about 0.25 wt % to about 2.00 wt %,alternatively ranging from about 0.37 wt % to about 0.75 wt %, andalternatively ranging from about 0.45 wt % to about 0.63 wt %. Theanti-inflamatory agent(s) such as panthenol offer the potential toreduce redness and irritation of the skin, while also supplementing themoisturizing and lubricity of the moisturizing lotion composition.

As will be described in more detail below, in embodiments where themoisturizing lotion composition is used to enhance the antimicrobialefficacy of one or more secondary compounds applied to the skin,panthenol may work together and synergistically with the aloe vera tofurther sooth skin irritation and further increase the antimicrobialefficacy of such secondary compounds.

Embodiments of the moisturizing lotion composition can include one ormore cationic polymers such as guar gum, guar gum modified withhydroxyalkyl groups, guar gum modified with hydroxypropyl groups, orcombinations thereof. Guar gum is commercially available as Jaguar®available from Rhodia. The hydroxyalkyl groups may include alkyl groupswith any number of carbon atoms. In such embodiments, the cationicpolymer(s) (e.g., guar gum) have a concentration (expressed as a wt % ofthe moisturizing lotion composition) ranging from about 0.17 wt % toabout 0.70 wt %, alternatively ranging from about 0.26 wt % to about0.53 wt %, and alternatively ranging from about 0.31 wt % to about 0.44wt %. Such cationic polymers offer the potential to provide protectionagainst disruptions of the cell surface by surfactants.

Embodiments of the moisturizing lotion composition can include one ormore film forming barriers such as jojoba oil. In such embodiments, thejojoba oil has a concentration (expressed as a wt % of the moisturizinglotion composition) ranging from about 0.05 wt % to about 0.20 wt %,alternatively ranging from about 0.07 wt % to about 0.15 wt %, andalternatively ranging from about 0.09 wt % to about 0.13 wt %. Filmbarriers such as jojoba oil offer the potential to limit moisturetransfer from or through the skin. More particularly, jojoba oil maylimit transepidermal water loss from the skin. In addition, jojoba oilmay act as an emollient and/or be used to regulate the viscosity of themoisturizing lotion composition.

In some embodiments, the film forming barriers may include argan oil inaddition to or as an alternative to jojoba oil. In such embodiments, theargan oil has a concentration (expressed as a wt % of the moisturizinglotion composition) ranging from about 0.02 wt % to about 0.30 wt %,alternatively ranging from about 0.03 wt % to about 0.08 wt %, andalternatively ranging from about 0.04 wt % to about 0.07 wt %.

The one or more film forming layers such as jojoba oil and argan oilform a barrier layer or residue layer adjacent or proximal the skin,while one or more other compounds within the moisturizing lotioncomposition remain suspended above the skin in an aqueous orsemi-aqueous state. Consequently, in embodiments where the moisturizinglotion composition is used to enhance the antimicrobial efficacy of oneor more secondary compound(s) applied to the skin, the residue layer mayform a physical barrier that reduces contact between the skin and theone or more secondary compound(s). Such buffering offers the potentialto reduce irritation of the skin by the secondary compound(s), allowhigher concentrations of antimicrobial agents in the secondarycompound(s) to be applied to the skin, allow prolonged skin exposuretimes for the antimicrobial agents in the secondary compound(s), orcombinations thereof. The argan oil may also act as an anti-wrinkleagent. Based on some testing, it is believed that argan oil alone or viaa synergistic effect when used in combination with chamomilla recutitaextract may provide an enhanced analgesic (e.g., pain relieving)benefit.

Embodiments of the moisturizing lotion composition can include anemollient such as butyrospermum parkii (shea butter) or shea butterbased esters. In such embodiments, the emollient (e.g., the shea butteror shea butter based esters) has a concentration (expressed as a wt % ofthe moisturizing lotion composition) ranging from about 0.02 wt % toabout 0.10 wt %, alternatively ranging from about 0.03 wt % to about0.08 wt %, and alternatively ranging from about 0.04 wt % to about 0.07wt %. A shea butter based ester emollient may be a commerciallyavailable product such as SheaLight™ available from Lipex. In someembodiments, the shea butter based ester emollient may be used incombination with other esters, silicone oils, vegetable oils, andsynthetic emollients.

Shea butter and shea butter based esters offer the potential to enhancesolubility of other compounds in the moisturizing lotion composition, aswell as secondary compounds. Without being limited to this or anyparticular theory, the increased solubility may contribute to a lessgreasy feel while forming a film barrier along the skin, which may limittransepidermal water loss from the skin. In addition, the increasedsolubility may provide better mixing with applied secondary compounds,which may facilitate entrapment or suspension of the secondary compoundswithin a particular volume of the moisturizing lotion compound. Thus, inembodiments where the moisturizing lotion composition is used to enhancethe antimicrobial efficacy of one or more secondary compounds applied tothe skin, inclusion of shea butter or shea butter based ester may causethe secondary compounds (e.g., hand sanitizer, etc.) to evaporate at aslower rate, thereby extending the period of time the hand sanitizerremains active on the skin.

Embodiments of the moisturizing lotion composition can include acationic low humidity humectant such hydroxypropylBis-hydroxyethyldimonium chloride (Cola® moist 200), which can also aidin moisturizing. In such embodiments, the cationic low humidityhumectant (e.g., the hydroxypropyl Bis-hydroxyethyldimonium chloride)has a concentration (expressed as a wt % of the moisturizing lotioncomposition) ranging from about 1.5 wt % to about 6.0 wt %,alternatively ranging from about 2.3 wt % to about 4.5 wt %, andalternatively ranging from about 2.7 wt % to about 3.8 wt %.

Embodiments of the moisturizing lotion composition can include a willowbark extract such as salix nigra willow bark extract. In suchembodiments, the willow bark extract (e.g., the salix nigra willow barkextract) has a concentration (expressed as a wt % of the moisturizinglotion composition) ranging from about 0.05 wt % to about 0.20 wt %,alternatively ranging from about 0.07 wt % to about 0.15 wt %, andalternatively ranging from about 0.09 wt % to about 0.13 wt %.

Willow bark extract includes salicylic acid, which is ananti-inflammatory agent. Additionally, willow bark extract may providemoisturizing, cleansing, bactericidal, viralcidal, and skin toningbenefits. Thus, in embodiments where the moisturizing lotion compositionis used to enhance the antimicrobial efficacy of one or more secondarycompounds applied to the skin, the salicylic acid in the willow barkextract may work together with the panthenol and the aloe vera tofurther sooth skin irritation, and further increase the antimicrobialefficacy of such secondary compounds in the manner previously described.In addition, the willow bark extract may increase the antimicrobialproperties of the moisturizing lotion composition without the additionor use of a secondary compound. Still further, the willow bark extractoffers potential analgesic (e.g., pain relieving) benefits alone andwhen used in combination with one or more secondary compounds asdisclosed herein.

Embodiments of the moisturizing lotion composition can include an alphahydroxyl acid such as citric acid. In such embodiments, the alphahydroxyl acid (e.g., the citric acid) has a concentration (expressed asa wt % of the moisturizing lotion composition) ranging from about 0.05wt % to about 0.20 wt %, alternatively ranging from about 0.07 wt % toabout 0.15 wt %, and alternatively ranging from about 0.09 wt % to about0.13 wt %. The alpha hydroxyl acid can be used to adjust the PH of themoisturizing lotion composition, and further, can be used as a chelatingagent to bind metals within the composition and enhance the solubilityof the metals. Citric acid also offers the potential to promote skinexfoliation and regeneration.

Embodiments of the moisturizing lotion composition can include lipids ormonoglycerides such as glyceryl stearate. In such embodiments, thelipids or monoglycerides (e.g., the glyceryl stearate) has at aconcentration (expressed as a wt % of the moisturizing lotioncomposition) ranging from about 0.25 wt % to about 1.00 wt %,alternatively ranging from about 0.37 wt % to about 0.75 wt %, andalternatively ranging from about 0.45 wt % to about 0.63 wt %. In someembodiments, the lipids or monoglycerides comprises Glyceryl StearateSE, which is self-emulsifying and contains sodium stearate and/orpotassium stearate. In some embodiments, Glyceryl Stearate SE may alsobe used as a surfactant to enhance mixing of the moisturizing lotioncomposition and one or more secondary compounds added to the skin (e.g.,alcohol, ethanol, vinegar, bleach, or hand sanitizer), thereby providingenhanced dispersion of secondary compounds (e.g., antimicrobial agents)throughout an applied film layer.

Embodiments of the moisturizing lotion composition can include one ormore anti-oxidant agent. Examples of suitable anti-oxidant agentsinclude, without limitation, Vitamin A, Vitamin C, Vitamin D, Vitamin E,Vitamin E tocopherol acetate beta-carotene, selenium, and zinc. In suchembodiments, the antioxidants have a concentration (expressed as a wt %of the moisturizing lotion composition) ranging from about 0.01 wt % toabout 5 wt %.

Embodiments of the moisturizing lotion composition can include one ormore antimicrobial compounds with antifungal and/or antibacterialproperties. Examples of suitable compounds with antifungal and/orantibacterial properties include Germall® Plus and Liquid Germall® Plus,each of which includes preservative diazolidinyl urea and iodopropynylbutylcarbamate in propylene glycol. In such embodiments, the LiquidGermall® Plus has a concentration (expressed as a wt % of themoisturizing lotion composition) ranging from about 0.15 wt % to about0.60 wt %, alternatively ranging from about 0.22 wt % to about 0.45 wt%, and alternatively ranging from about 0.27 wt % to about 0.38 wt %.The Liquid Germall® Plus provides diazolidinyl urea at a concentration(expressed as a wt % of the moisturizing lotion composition) rangingfrom about 0.14 wt % to about 0.55 wt %, and provides iodopropynylbutylcarbamate at a concentration (expressed as a wt % of themoisturizing lotion composition) ranging from about 0.01 wt % to about0.05 wt %. Thus, in some embodiments, the moisturizing lotioncomposition may itself exhibit some antimicrobial properties without theaddition of a secondary compound (e.g., alcohol, ethanol, vinegar,bleach, hand sanitizer, etc.).

Embodiments of the moisturizing lotion composition can include a longchain organic alcohol such as cetyl alcohol. In such embodiments, thelong chain organic alcohol (e.g., cetyl alcohol) has a concentration(expressed as a wt % of the moisturizing lotion composition) rangingfrom about 0.25 wt % to about 1.00 wt %, alternatively ranging fromabout 0.37 wt % to about 0.75 wt %, and alternatively ranging from about0.45 wt % to about 0.63 wt %. A long chain organic alcohol such as cetylalcohol provides emulsion stabilization, viscosity control, andantimicrobial properties.

Embodiments of the moisturizing lotion composition can include one ormore surfactants and emulsion agents such as polysorbate-20. In suchembodiments, the surfactant(s) and emulsion agent(s) (e.g., thepolysorbate-20) has a concentration (expressed as a wt % of themoisturizing lotion composition) ranging from about 0.25 wt % to about1.00 wt %, alternatively ranging from about 0.37 wt % to about 0.75 wt%, and alternatively ranging from about 0.45 wt % to about 0.63 wt %.The surfactants and emulsion agents reduce the surface tension betweenthe moisturizing lotion composition and any secondary compounds added tothe skin (e.g., alcohol, ethanol, vinegar, bleach, hand sanitizer,etc.), thereby allowing more complete mixing therebetween and enhanceddispersion of antimicrobial agents throughout an applied film layer.

As previously described, the ingredients of the moisturizing lotioncomposition are mixed in a solvent, and in particular water, to form anaqueous solution. In general, the water can be deionized water,distilled water, or combinations thereof. In some embodiments, water isin the form of a water-based gel or foam. In embodiments describedherein, the water generally defines the balance of the moisturizinglotion composition. In particular, the water has a concentration(expressed as a wt % of the moisturizing lotion composition) rangingfrom about 30 wt % to about 90 wt %, alternatively ranging from about 40wt % to about 85 wt %, and alternatively ranging from about 58 wt % toabout 80 wt %.

The moisturizing lotion composition can also include one or morepreservatives. Examples of suitable preservatives include LiquidGermall™ Plus, which can also function as an antimicrobial as previouslydescribed. In such embodiments, the preservative(s) has a concentration(expressed as a wt % of the moisturizing lotion composition) rangingfrom about 0.01 wt % to about 4.0 wt %, and alternatively from 0.10 wt %to about 1.5 wt %. In general, the preservative(s) aid in stabilizingthe moisturizing lotion composition.

In general, embodiments of moisturizing lotion compositions disclosedherein can be applied in a variety of suitable manners and to treat avariety of conditions and symptoms. For example, embodiments of themoisturizing lotion composition can be dispensed by an atomizer, pumpspray, or propellant based fluid, gel, or foam dispenser. In addition,the moisturizing lotion compositions can be applied to the face (e.g.,prior to make-up application) to hydrate the skin, prevent poreclogging, treat acne, or reduce inflammation from acne on the face.Similarly, the moisturizing lotion compositions can be applied otherparts of the body (e.g., the trunk) for the foregoing benefits. Further,moisturizing lotion compositions can be used as a skin pre-treatment forapplication to the skin prior to applying a subsequent medical treatmentand/or compound thereto. Without being limited by this or any particulartheory, the hydration of the skin by embodiments of moisturizing lotioncompositions disclosed herein may act to make the skin more permeable todermal or transdermal medical applications following the use of themoisturizing lotion composition. For example, the moisturizing lotioncompositions can be applied concurrently (e.g., mixed with) othermedical compounds, thereby acting directly as a dermal or transdermaldelivery agent.

Two or more of the compounds in embodiments of moisturizing lotioncompositions described herein may work together to produce beneficialsynergistic effects. Without being limited by this or any particulartheory, it is believed such synergistic effects may depend on or resultfrom the relative concentrations of such two or more compounds. Morespecifically, in embodiments of moisturizing lotion compositionsdisclosed herein, the ratio of the concentration of aloe vera in themoisturizing lotion composition to the concentration of vervain extractin the moisturizing lotion composition ranges from 0.80 to 1.20,alternatively ranges from 0.90 to 1.10, alternatively ranges from 0.95to 1.05, and alternatively is 1.0. In addition, in embodiments ofmoisturizing lotion compositions disclosed herein including propyleneglycol and panthenol, the ratio of the concentration of propylene glycolin the moisturizing lotion composition to the concentration of panthenolin the moisturizing lotion composition ranges from 40.0 to 60.0,alternatively ranges from 45.0 to 55.0, and alternatively is 50.0.Further, in embodiments of moisturizing lotion compositions disclosedherein including panthenol and chamomilla recutita extract, the ratio ofthe concentration of panthenol in the moisturizing lotion composition tothe concentration of chamomilla recutita extract in the moisturizinglotion composition ranges from 3.0 to 7.0, alternatively ranges from 4.0to 6.0, alternatively ranges from 4.5 to 5.5, and alternatively is 5.0.Still further, in embodiments of moisturizing lotion compositionsdisclosed herein including propylene glycol and chamomilla recutitaextract, the ratio of the concentration of propylene glycol in themoisturizing lotion composition to the concentration of chamomillarecutita extract in the moisturizing lotion composition ranges from200.0 to 300.0, alternatively ranges from 225.0 to 275.0, andalternatively is 250.0. In embodiments of moisturizing lotioncompositions disclosed herein including chamomilla recutita extract andwillow bark extract, the ratio of the concentration of chamomillarecutita extract in the moisturizing lotion composition to theconcentration of willow bark extract in the moisturizing lotioncomposition ranges from 0.80 to 1.20, alternatively ranges from 0.90 to1.10, alternatively ranges from 0.95 to 1.05, and alternatively is 1.0.And in embodiments of moisturizing lotion compositions disclosed hereinincluding chamomilla recutita extract and argan oil, the ratio of theconcentration of chamomilla recutita extract in the moisturizing lotioncomposition to the concentration of argan oil in the moisturizing lotioncomposition ranges from 1.0 to 3.0, alternatively ranges from 1.5 to2.5, alternatively 2.0.

In some embodiments, the moisturizing lotion composition is used on skinto enhance the antimicrobial efficacy of one or more secondary compoundsthat are also applied to the skin. Such secondary compounds exhibitingantimicrobial properties include, without limitation, hand sanitizer,alcohol, vinegar, bleach (e.g., sodium hypochlorite), mixtures thereof,as well as compounds known in the art as having antimicrobialproperties. In some embodiments, a secondary compound includes alcohol(e.g., isopropyl alcohol, ethanol, ethyl alcohol, etc.) having aconcentration (expressed as a wt % of the secondary compound) rangingfrom about 40 wt % to about 100 wt %, alternatively from about 50 wt %to about 90 wt %, and alternatively from about 60 wt % to about 80 wt %.In some embodiments, a secondary compound includes vinegar at aconcentration (expressed as a wt % of the secondary compound) rangingfrom about 0.5 wt % to about 50 wt %, alternatively from about 2 wt % toabout 70 wt %, and alternatively from about 5 wt % to about 100 wt %. Insome embodiments, a secondary compound includes bleach at aconcentration (expressed as a wt % of the secondary compound) rangingfrom about 0.5 wt % to about 5 wt %, alternatively from about 5 wt % toabout 60 wt %, and alternatively from about 10 wt % to about 100 wt %.

In embodiments where the moisturizing lotion composition is used toenhance the antimicrobial efficacy of one or more secondary compoundsapplied to the skin, the moisturizing lotion composition can be appliedto the skin before the secondary compound(s) to form an initial baselayer. The base layer may then be allowed to dry on the skin. Forexample, the base layer may be allowed to dry for a period of timeranging from about 5 seconds to 1 minute, alternatively 15 seconds toabout 5 minutes, and alternatively from about 30 seconds to 10 minutes.In other embodiments, no base layer drying time is provided. After theapplication of the moisturizing lotion composition as a base layer, oneor more secondary compounds may be applied to the skin. Without beinglimited by this or any particular theory, the moisturizing lotioncomposition protects the skin (e.g., forms a physical barrier) and/orenhances the resistance of the skin to the potentially negative impactsassociated with the secondary compounds such as inflammation of theskin, irritation, and drying of the skin. Further, the moisturizinglotion composition may extend the period of time the secondary compoundis effective for antimicrobial uses. For example, alcohol containedwithin hand sanitizer may evaporate at a slower rate when at leastpartially mixed with moisturizing lotion compositions described herein.

In other embodiments, the one or more secondary compounds are appliedbefore application of the moisturizing lotion composition, the one ormore secondary compounds are applied concurrently with the moisturizinglotion composition, or a combination thereof (before and duringapplication of the moisturizing lotion composition). In still otherembodiments, the one or more secondary compounds may be providedpremixed with the moisturizing lotion composition. In addition, aspreviously described, some embodiments of the moisturizing lotioncomposition described herein exhibit antimicrobial properties withoutthe addition or use of a secondary compound.

Embodiments of the moisturizing lotion composition described herein canbe used in connection with a lavage procedure in which the one or moresecondary compounds are employed as an aqueous flush solution. Forexample, the moisturizing lotion composition may be applied to the nasaltissues, and a lavage solution including the one or more secondarycompounds such as vinegar and/or alcohol may be used to flush particlesfrom the nasal tissues.

To further illustrate various illustrative embodiments of the presentdisclosure, the following non-limiting examples are provided.

Example 1

As previously described, embodiments of moisturizing lotion compositionsdisclosed herein include one or more of the following: skin conditioningagent(s), aloe vera, algae extract, vervain extract, ananti-inflammatory agent, cationic polymer(s), film forming barrier(s),emollient(s), cationic low humidity humectant(s), willow bark extract,antifungal and/or antibacterial compound(s), cetyl alcohol,surfactant(s) and/or emulsion agent(s), anti-wrinkle agent(s), skinconditioning agent(s), alpha hydroxyl acid(s), lipid(s) and/ormonoglyceride(s), and anti-oxidant agent(s). The formulation of oneexemplary embodiment of a moisturizing lotion composition in accordancewith the principles described herein is provided in Table 1 below.

TABLE 1 wt % Ingredients (of the composition) Deionized water 64.25Propylene glycol 25.00 Cola ® moist 200 3.00 Algae extract 2.00 Aloevera 1.00 Vervain extract 1.00 Fragrance oil 0.60 Cetyl Alcohol 0.50Glyceryl Stearate SE 0.50 Panthenol 0.50 Polysorbate-20 0.50 Jaguar HP-80.35 Liquid Germall ® plus 0.30 Chamomilla recutita extract 0.10 Citricacid 0.10 Jojoba oil 0.10 Willow bark extract 0.10 Argan oil 0.05 LipexSheaLight ™ 0.05 Total 100

Example 2

Embodiments of moisturizing lotion compositions disclosed herein wereused to treat skin conditions including eczema, herpes zoster,fibromyalgia, neuropathy, and pain in human patients over a period oftime. The symptoms experienced by each patient were identified, and theeffectiveness of the treatments based on patient feedback were trackedon a weekly basis. The patients rated the effectiveness of thetreatments on a scale—Effective (“E”), Somewhat Effective (“S”), Neutral(“N”), or Ineffective (“I”) (listed in order of decreasing effectivenesswith Effective being the highest degree of effectiveness and Ineffectivebeing the lowest degree of effectiveness). In cases where the patientpreviously employed a different therapy to treat the symptom, theeffectiveness of the treatments with the moisturizing lotioncompositions disclosed herein was evaluated in comparison to thepreviously employed therapy. In other words, the previously employedtherapy served as a baseline against which the effectiveness oftreatments with the moisturizing lotion compositions disclosed hereinwere compared. The results of the treatments are summarized in Table 2below.

As shown in Table 2 below, each patient treated indicated Effectivetreatment of the condition and associated symptoms was experienced, andin particular, indicated Effective treatment was experienced relativelyquickly or immediately within the first week of treatment. In addition,all but one of the patients treated (Patient No. 15) indicated thetreatments were Effective over the entire duration of the treatments.For example, Patient Nos. 1, 4, 5, 8, 13, and 14 indicated treatmentswere Effective over a period of at least 8 weeks.

Although it is not explicitly shown in Table 1, each patient listed inTable 1 indicated onset of benefit(s) (e.g., pain relief) within five(5) minutes of application of the moisturizing lotion composition, andfurther, each patient listed in Table 1 indicated such benefits lastedat least 7 hours after application, and more generally between 7 and 72hours after application depending on the particular condition and levelof pain. In addition, although it is not explicitly shown in Table 1,patient number 7 indicated complete healing of radiation burns followingtwo weeks of treatments with the moisturizing lotion composition, whichis significantly less than the period of time typically expected tofully heal radiation burns via conventional treatments with steroidcreams (about four months), which at least suggests the moisturizinglotion composition improved rate of healing of the radiation burn by asmuch as eight times (8×) as compared to a conventional treatment.

Weeks of Patient Symptoms Application No. Age Condition Dryness ItchingSwelling Redness Pain Tingling Burning 1 2 4 8 Previous Therapies 1 46Eczema x x x E E E E Eucrisa 2 56 Eczema x x x E E Clobetasol,Prednisone, Triamcinolone 3 87 Eczema, Herpes x x E 0.25% Dexamethasonezoster cream 4 Herpes zoster x x E E E E Valtrex 5 63 Fibromyalgia x E EE E 6 62 Irritated legs x x E E N/A 7 Radiation burn x x x E E EVaseline 8 57 Neuropathy x x E E E E Gabapentin 9 85 Neuropathy x x E E10 Neuropathy, Pain x E Gabapentin in neck and temples 11 64 Pain inbody x E E N/A 12 Pain in both legs x E and feet 13 38 Pain in jaw and xx E E E E BC powder tooth 14 62 Pain in right leg x E E E E N/A 15 Painsiatic x E E S N CBD oil E = Effective S = Somewhat Effective N =Neutral I = Ineffective

While exemplary embodiments have been shown and described, modificationsthereof can be made by one skilled in the art without departing from thescope or teachings herein. The embodiments described herein areexemplary only and are not limiting. Many variations and modificationsof the systems, apparatus, and processes described herein are possibleand are within the scope of the disclosure. Accordingly, the scope ofprotection is not limited to the embodiments described herein, but isonly limited by the claims that follow, the scope of which shall includeall equivalents of the subject matter of the claims. Unless expresslystated otherwise, the steps in a method claim may be performed in anyorder. The recitation of identifiers such as (a), (b), (c) or (1), (2),(3) before steps in a method claim are not intended to and do notspecify a particular order to the steps, but rather are used to simplifysubsequent reference to such steps.

What is claimed is:
 1. A moisturizing lotion composition, comprising:water; propylene glycol having a concentration of 21.0 to 37.5 wt % ofthe moisturizing lotion composition; aloe vera having a concentration of0.50 to 4.0 wt % of the moisturizing lotion composition; vervain extracthaving a concentration of 0.50 to 4.0 wt % of the moisturizing lotioncomposition; willow bark extract having a concentration of 0.50 to 0.20wt % of the moisturizing lotion composition; and chamomilla recutitaextract having a concentration of 0.05 to 0.40 wt % of the moisturizinglotion composition; wherein a ratio of the concentration of thepropylene glycol to the concentration of the chamomilla recutita extractis between 4.5 and 5.5.
 2. The moisturizing lotion composition of claim1, further comprising: argan oil having a concentration of 0.02 to 0.30wt % of the moisturizing lotion composition.
 3. The moisturizing lotioncomposition of claim 2, further comprising: an algae extract having aconcentration of 1.5 to 3.0 wt % of the moisturizing lotion composition.4. The moisturizing lotion composition of claim 2, further comprising:panthenol having a concentration of 0.25 to 2.0 wt % of the moisturizinglotion composition.
 5. The moisturizing lotion composition of claim 1,wherein the water is de-ionized water having a concentration of 40 to 85wt % of the moisturizing lotion composition.
 6. The moisturizing lotioncomposition of claim 1, wherein the concentration of the propyleneglycol is 22.5 wt % to 31.3 wt %.
 7. The moisturizing lotion compositionof claim 1, wherein the concentration of the aloe vera is 0.9 to 1.25 wt%.
 8. The moisturizing lotion composition of claim 1, wherein theconcentration of the chamomilla recutita extract is 0.09 to 0.13 wt % ofthe moisturizing lotion composition.
 9. The moisturizing lotioncomposition of claim 1, wherein a ratio of the concentration of the aloevera to the concentration of the vervain extract is between 0.90 and1.10.
 10. The moisturizing lotion composition of claim 1, furthercomprising a secondary compound including alcohol having a concentrationof 40 to 100 wt % of the secondary compound.
 11. A moisturizing lotioncomposition, comprising: de-ionized water; propylene glycol having aconcentration of 12.5 to 50.0 wt % of the moisturizing lotioncomposition; aloe vera having a concentration of 0.5 to 2.0 wt % of themoisturizing lotion composition; vervain extract having a concentrationof 0.50 to 4.0 wt % of the moisturizing lotion composition; chamomillarecutita extract having a concentration of 0.07 to 1.5 wt % of themoisturizing lotion composition; and panthenol having a concentration of0.25 to 2.0 wt % of the moisturizing lotion composition; and willow barkextract having a concentration of 0.09 to 0.13 wt % of the moisturizinglotion composition; wherein a ratio of the concentration of thepropylene glycol to the concentration of the chamomilla recutita extractis between 4.5 and 5.5; wherein a ratio of the concentration of thepropylene glycol to the concentration of the panthenol is between 45.0and 55.0.
 12. The moisturizing lotion composition of claim 11, furthercomprising an antimicrobial compound.
 13. The moisturizing lotioncomposition of claim 12, wherein the antimicrobial compound comprises:diazolidinyl urea having a concentration of 0.14 to 0.55 wt % of themoisturizing lotion composition; or iodopropynyl butylcarbamate having aconcentration 0.01 to 0.05 wt % of the moisturizing lotion composition.14. The moisturizing lotion composition of claim 11, further comprisinga secondary compound including alcohol having a concentration of 40 to100 wt % of the secondary compound.
 15. The moisturizing lotioncomposition of claim 11, wherein a ratio of the concentration of thechamomilla recutita extract to the concentration of the willow barkextract is between 0.80 and 1.20.
 16. The moisturizing lotioncomposition of claim 15, further comprising argan oil having aconcentration of 0.04 to 0.07 wt % of the moisturizing lotioncomposition, wherein a ratio of the concentration of the chamomillarecutita extract to the concentration of the argan oil is between 1.5and 2.5.
 17. The moisturizing lotion composition of claim 11, wherein aratio of the concentration of the panthenol to the concentration of thechamomilla recutita extract is between 4.0 and 6.0.